ValiSeek Clinical Development Update

RNS Number : 7842Y

ValiRx PLC

08 March 2017

 

ValiRx Plc

("ValiRx" or "the Company")

VALISEEK CLINICAL DEVELOPMENT UPDATE

London, UK., 8 March 2017: ValiRx Plc (AIM: VAL), a clinical stage biotechnology company, is pleased to provide an update on the clinical development of the joint venture between ValiRx and Tangent Reprofiling Limited.

ValiSeek was formed to progress the novel cancer treatment drug, VAL401, into Clinical Efficacy trials for the treatment of lung cancer and other oncology indications.

Since the announcement by the Company on 3 November 2016, regarding the commencement of dosing of patients, ValiSeek has made several significant steps of progression within the trial.

Second site actively recruiting patients into the trial.

On 1 December 2016, the Company reported on the acceptance by the ethics committee of the JSC Neo Medi Clinic, Tbilisi, Georgia, to be the Company's second trial site.  The Company confirms that the Ministry of Health have approved the site and that all contractual and logistical procedures have been finalised and that this second site is now actively recruiting patients into the trial.

Permission sought to initiate a third clinical site in Georgia

Further to the initiation of the second site, the Company announces that it has received approval from the ethics committee of the Research Institute of Clinical Medicine, Tbilisi and is in the process of submitting an application for full regulatory approval from the Ministry of Health in Georgia to initiate this third clinical site in Tbilisi.

In light of the Company's earlier experiences, both in terms of recruitment and testing of VAL401, the decision to include the Research Institute of Clinical Medicine, Tbilisi, as a third site, enables the differing specialities of clinics and investigators to be combined to provide the optimal team for the Company's trial.  With this third site anticipated to commence recruiting patients by April 2017, the Company will extend its recruitment period into Q2 2017, in order to maximise the potential for the full co-operation between the sites.

Protocol Amendments

In addition, ValiSeek has achieved approval of several protocol and documentation amendments and updates both to the ethics committees of all three sites and to the Ministry of Health, Georgia.  In addition to clarifying instructions to the clinicians, these updates confirm the intention of a preliminary datalock on completion of the collection of all pharmacokinetic samples.  This will enable a mid-trial data release.

 Dr Suzy Dilly, CEO of ValiSeek, commented: "The set-up and planning for the addition of a third site is a statement of confidence and evidence that we are all working towards completing recruitment and collecting good quality data within a reasonable timeframe.  I thank the team at Clinical Accelerator for achieving this.  The amendment for preliminary datalock is important as it allow us both to access early data from the trial and to conduct a robust analysis of the early safety, tolerability and pharmacokinetic data, but without compromising the quality of life and survival data that will continue to be gathered".

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For more information, please contact:

ValiRx plc	Tel: [phone] www.valirx.com
Dr Satu Vainikka, Chief Executive	Tel: [phone]
Tarquin Edwards, Head of Communications.	Tel: [phone] [e-mail]
Mark Treharne, Corporate Development Manager	Tel: [phone] [e-mail]

Notes for Editors

About ValiSeek

ValiSeek Limited ("ValiSeek") is a joint venture ("JV") company between ValiRx Plc and Tangent Reprofiling Limited, part of the SEEK Group. ValiSeek was formed to progress the drug VAL401 through its remaining preclinical development and towards Phase II trials for the treatment of lung cancer and other oncology indications.

About ValiRx

ValiRx is a biotechnology oncology focused company specialising in developing novel treatments for cancer and associated biomarkers.  It aims to make a significant contribution in "precision" medicine and science, namely to engineer a breakthrough into human health and well-being, through the early detection of cancer and its therapeutic intervention.

The Company's business model focuses on out-licensing therapeutic candidates early in the development process. By aiming for early-stage value creation, the company reduces risk considerably while increasing the potential for realising value. The group is already in licensing discussions with major players in the oncology field.

ValiRx's two classes of drugs in development, which each have the potential for meeting hitherto unmet medical needs by existing methods, have worldwide patent filings and agreed commercial rights.   They originate or derive from Word class institutions, such as Cancer Research UK and Imperial College. 

Until recently, cancer treatments relied on non-specific agents, such as chemotherapy.  With the development of target-based agents, primed to attack cancer cells only, less toxic and more effective treatments are now possible. New drugs in this group-such as those in ValiRx's pipeline-promise to greatly improve outcomes for cancer patients.

The Company listed on the AIM Market of the London Stock Exchange in October 2006 and trades under the ticker symbol: VAL.

 

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